Method and apparatus for treating medical conditions

ABSTRACT

A method and apparatus for treating a condition in a patient such as BPH, irretractable infection, cyst, fibroid, or any mass such as prostate or breast cancer, skin cancer, melanoma, or any other soft tissue cancerous or benign mass, employs a unique, three-dimensional software-controlled electronic amplifier array using arbitrary waveforms that dynamically and proportionally steer electrical currents by using two or more current vector paths, sequentially or simultaneously, through a defined area containing electrically-conductive ionic solutions so as to obtain 100% thermal heating or hyperthermia through the defined area. The condition is treated or a mass is destroyed with a minimally-invasive treatment which requires no radiation or chemotherapy which could be harmful to the patient.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is continuation-in-part of co-pending U.S. patentapplication Ser. No. 14/203,633, filed Mar. 11, 2014, which in turn is adivisional of, commonly owned, U.S. patent application Ser. No.13/569,574, filed Aug. 8, 2012, now U.S. Pat. No. 8,706,258, which inturn is based upon and claims the benefit of the filing dates ofcommonly owned U.S. Provisional Patent Application Ser. No. 61/521,049,filed Aug. 8, 2011, and commonly owned U.S. Provisional PatentApplication Ser. No. 61/521,235, filed Aug. 8, 2011, each of which isincorporated herein by reference in its entirety.

FIELD OF THE INVENTION

This invention is directed to the treatment of masses, such as prostateor breast cancer, or any other soft tissue, malignant or benign orinflammatory lesions, where standard surgery or therapy makes itdifficult to remove the mass in its entirety due to proximity to otherorgans, vasculature, or other critical tissue or to effectively treatthe mass or symptoms associated or caused by the mass or disease withthe organ being targeted by the procedures and devices disclosed herein.More directly, the cancerous mass or tissue is destroyed orsubstantially altered in situ, which may allow eradication of masses,destruction or alteration of the tissue, or relief of symptomsassociated with a condition that may have previously been inoperable ornot possible.

BACKGROUND OF THE INVENTION

According to the American Cancer Society in 2014, about 585,720Americans are expected to die of cancer, almost 1,600 people per day.Cancer is the second most common cause of death in the US, exceeded onlyby heart disease, accounting for nearly one of every four deaths. Thisdisease affects people of all ages, and treatment options currentlyinclude surgery, radiation therapy, immunotherapy, cryotherapy, lasertherapy, and chemotherapy. Surgery, alone or in conjunction with othertreatments, is used in more than nine out often cases. Prostate canceris the most common non-skin malignancy in men and the second leadingcause of cancer death. The ACS estimates over 230,000 new cases in 2015,the majority of which will have localized disease. Most of these menwill receive radical prostatectomy (RP) or external beam irradiation(EBRT).

Benign enlargement of the prostate (BPH) refers to the nonmalignantgrowth of the prostate observed very commonly in aging men. Thehistologic prevalence of BPH, which has been examined in several autopsystudies around the world, is approximately 20% for men in their 40s,reaches 50% to 60% for men in their 60s, and is 80% to 90% for men intheir 70s and 80s. The condition becomes a clinical entity if and whenit is associated with subjective symptoms, the most common manifestationbeing lower urinary tract symptoms (LUTS). Typically the patient willseek medical care because of these symptoms or because of an inabilityto urinate. The evaluation, often done by a urologist, will reveal theenlarged gland, and a number of treatment options will be proposed,including medical therapy (α-adrenergic receptor blockers and5α-reductase inhibitors), minimally invasive therapies (transurethralmicrowave therapy (TUMT) and transurethral needle ablation (TUNA)), andsurgery (transurethral resection of the prostate (TURP) and openprostatectomy). The latter therapies are often reserved for men withvery large prostates.

Prostatitis describes a combination of infectious diseases (acute andchronic bacterial prostatitis), chronic pelvic pain syndrome, andasymptomatic inflammation. Its prevalence ranges from 2.2 to 9.7% of themale population. Prostatitis has been diagnosed in 1% of all primarycare physician visits and in 8% of all visits to urologists. In a surveyof 31,681 men, 16% had a self-reported history of prostatitis.Participants reporting a history of benign prostatic hyperplasia (BPH)had 7.7-fold greater odds of a history of prostatitis, those with severelower urinary tract symptoms had 2.8-fold greater odds of a history ofprostatitis, and men with moderate lower urinary tract symptoms had1.8-fold greater odds of prostatitis. According to the NationalInstitutes of Health, prostatitis accounts for 25% of all office visitsinvolving the genitourinary system by young and middle-aged men. Despitethe fact that prostatitis can be caused by common colon bacteria, inonly 5-10% of the cases can bacteria be cultured. Therefore, theoverwhelming majority of cases are caused by an idiopathic inflammatoryprocess. After a trial of antibiotics, which are usually not successful,analgesics and warm baths are recommended to alleviate symptoms ofprostatodynia (painful prostate) and nonbacterial prostatitis.

Uterine fibroids (leiomyomata) are noncancerous growths that develop inor just outside a woman's uterus. Uterine fibroids develop from normaluterus muscle cells that start growing abnormally. As the cells grow,they form a benign tumor. Fibroids are extremely common and when largeare associated with prolonged menstrual periods, heavy bleeding duringperiods, bloating or fullness or pain in the abdomen or pelvis,constipation, and pain with intercourse. Fibroids can be detected by aphysical exam or imaging (usually ultrasound). A number of non-surgicaloptions for treating symptomatic fibroids include hormones (estrogen,progesterone, or a combination) which can help reduce heavy periodscaused by uterine fibroids, Lupron, which stops menstrual periods andshrinks uterine fibroids, and an intrauterine device (IUD) withlevonorgestrel which reduces heavy periods. Surgical options includemyomectomy, which removes uterine fibroids while leaving the uterus inplace, and hysterectomy to remove the entire uterus and all uterinefibroids and can be done by an open or laparoscopic procedure.Hysterectomy is the second most frequently performed surgical procedure(after cesarean section) for U.S. women. Approximately 600,000hysterectomies are performed annually in the United States, andapproximately 20 million American women have had a hysterectomy. Womenwho are not surgical candidates can undergo uterine artery embolization(UAE), a procedure that cuts off blood flow to a uterine fibroid,causing it to shrink. This procedure is associated with substantial painand/or discomfort.

While surgery and radiation are the most common treatments for thesediseases, they are associated with significant side effects andlong-term decrease in quality of life. In addition, surgery or radiationare not used for prostatitis. Patients are seeking less invasive methodsof treatment where only the lesion(s) are treated and the majority ofthe gland or organ is left in-tact. In men with prostate cancer, upwardsof one in three (over 80,000 men) are candidates for focal therapy,where just the lesion is treated and the surrounding “normal” tissue isspared. For men with prostatitis, surgery or radiation have not been anoption, and the majority of patients continue to have symptoms.

Melanoma is a type of skin cancer which forms from melanocytes(pigment-containing cells in the skin). In women, the most common siteis the legs, and melanomas in men are most common on the back. It isparticularly common among Caucasians, especially northern Europeans andnorthwestern Europeans, living in sunny climates. There are higher ratesin Oceania, North America, Europe, Southern Africa, and Latin America.This geographic pattern reflects the primary cause, ultraviolet light(UV) exposure in conjunction with the amount of skin pigmentation in thepopulation. Melanocytes produce the dark pigment, melanin, which isresponsible for the color of skin. These cells predominantly occur inskin, but are also found in other parts of the body, including the boweland the eye (see, uveal melanoma). Melanoma can originate in any part ofthe body that contains melanocytes.

Treatment of melanoma includes surgical removal of the tumor. Ifmelanoma is found early, while it is still small and thin, and if it iscompletely removed, the chance of cure is high. The likelihood that themelanoma will come back or spread depends on how deeply it has gone intothe layers of the skin. For melanomas that come back or spread,treatments include chemo- and immunotherapy, or radiation therapy. Fiveyear survival rates in the United States are on average 91%.

Melanoma is less common than other skin cancers. However, it is muchmore dangerous if it is not found in the early stages. It causes themajority (75%) of deaths related to skin cancer. Globally, in 2012,melanoma occurred in 232,000 people and resulted in 55,000 deaths.Australia and New Zealand have the highest rates of melanoma in theworld. It has become more common in the last 20 years in areas that aremostly Caucasian. There is a great need for more effective treatmentmethods for melanoma.

OBJECTS OF THE INVENTION

It is an object of the invention to provide a method and apparatus fortreating a malignant, benign, or inflammatory mass or tissue.

It is also an object of the invention to provide a method and apparatusfor treating solid cancerous tumors involving the prostate, breast,kidney, brain liver, pancreas, or any organ where a solid tumor mayreside.

It is also an object of the invention to provide a method and apparatusfor treating solid cancerous tumors that may reside inside an organ orgland (focal therapy)

It is also an object of the invention to provide a method and apparatusfor treating benign solid masses, for example, fibroids, that occupycertain organs.

It is also an object of the invention to provide a method and apparatusfor treating prostatitis and its associated symptoms.

It is a further object of the invention to provide a method andapparatus for treating a cancerous mass that may have been consideredinoperable.

It is a yet further object of the invention to provide a method fortreating a cancerous mass that comprises surrounding the cancerous masswith at least three shafts, each shaft having at least two electrodebands or contact points, and applying sufficient electrical current orenergy in dynamically and proportionally steered current vectors todestroy cancer cells.

It is a yet further object of the invention to provide an apparatuscomprising at least three electrode shafts, each electrode shaft havingat least two electrode bands or contact points and being capable ofapplying sufficient electrical current or energy in dynamically andproportionally steered current vectors to destroy cancerous cells.

It is a yet further object of the invention to provide a method andapparatus for treating a cancerous mass wherein the electrical currentapplied has waveforms that are chosen by proprietary software to beparticularly effective.

It is a further object of the invention to provide a method andapparatus for treating cancer where each electrode shaft comprisingelectrodes has a distal tip comprising a rigid dissolvable salt coatingor compound or a functional equivalent, to eliminate tissue damagewithin a patient after the electrode shaft is inserted.

It is a yet further object of the invention to provide a method andapparatus wherein each electrode band or contact point on a shaftcomprises a thermal sensor.

It is a yet further object of the invention to provide a method andapparatus wherein electrode patches are placed on the surface of theskin of a patient and the current directed to the target area in concertwith subcutaneous electrodes to generate a hot zone within a mass and onthe surface of the skin.

These and other objects of the invention will become more apparent fromthe description below taken in conjunction with the attached detaileddrawings.

SUMMARY OF THE INVENTION

Applying an electrical direct current (DC) through an ionic mass orionic solution produces heating or hyperthermia. Also, applying anelectrical alternating current (AC) through an ionic mass or liquidsolution produces heating or hyperthermia. The only difference betweenDC and AC currents applied through an ionic mass is that with DC currentone electrode is an anode and the other electrode is a cathode. Chemicalreactions occur at the two electrodes that take electron voltage, andcurrent applied to the electrodes and the first electrode in the ionicmass converts the energy into ionic current through the mass orsolution. At the second electrode the ionic current is converted backinto electron current of the opposite polarity. Electron current can beconducted through a metal conductor such as a wire where ionic currentcannot flow through a wire, only an ionic solution or ionic mass. WhenAC current is used, each of two electrodes where an AC voltage andcurrent are applied causes each electrode to convert the electroncurrent flow into an ionic current flow. However, when AC current isapplied through an ionic media, each electrode becomes an anode and acathode by changing functions, alternating back and forth at thefrequency of the AC current. Thus, AC or DC current will produce heatingthrough an ionic mass provided that an ionic solution exists insufficient density for an ionic current to flow and generate heat.

According to the invention, a method and apparatus are provided fordynamically and proportionately steering or selecting two or morecurrent vector paths, sequentially or simultaneously, for heating anddestroying cancerous cells within a mass. Other traditional devices usea single current path or devices that deliver current across two or morecurrent pathways. However, they cannot dynamically steer andproportionally induce hyperthermia by altering the voltage, currentamplitude, and pulse-widths, or employ arbitrary waveforms through eachpathway.

According to an aspect of the invention, an electrode system comprisesthree or more essentially non-conductive longitudinally extendingmembers or shafts that will each comprise two or more, preferably three,electrode bands or contact points. Each electrode band or contact pointis in electrical communication with an amplifier, and a thermal sensoris attached to each electrode band or contact point. Each thermal sensoris in electrical communication with a controller or processor. Theshafts are designed with a very small insertion diameter and are tippedwith a rigid dissolvable salt coating or compound, or a functionallyequivalent coating, to protect tissue within a patient. These shafts arepositioned strategically around and in close proximity to a mass to betreated.

According to another aspect of the invention, a method and apparatus useshafts with specifically designed electrodes that are electrically andmechanically manufactured to optimize the treatment for the specificcancerous mass and/or the organ to be treated. The shafts may simplycomprise electro-mechanical electrodes, or they may be designed to beinflatable with air or fluid, or to be dynamically cooled, or to allowfor mechanical stability to hold position during the treatment.

According to another aspect of the invention, electronic circuitrywaveforms are employed which include, but are not limited to, arbitrarywaveforms of any form, amplitude or pulse-width (sine, square, triangle,curved, damped-sinusoidal, positive or negative, with varying pulsewidth modulation) using direct current (DC) and/or alternating current(AC) and frequencies of voltage dependent upon the situation/mass andthe treatment required. The waveform shapes are generated by a processorunder software control interfaced with a computer. The energy is furtheramplified and delivered differentially between amplifiers without theuse of a ground return.

According to another aspect of the invention, the electrodeselectrically heat tissue in the mass, destroying the tissue. Theelectrodes are positioned around, but do not enter, the mass itself. Aprocessor will vary the voltage amplitude, current intensity andpulse-width to heat and maintain thermal averaging within the entiretargeted mass. This eliminates the possibility of cancer cells breakingfree and migrating to other areas of the body during the surgicalprocess. It also allows the mass to convert to scar tissue, which can beleft in place, or removed at a later time. The current pulses are keptwithin the area defined by the shaft placement via dynamic andproportional current steering as commanded via the processor so that aminimum of healthy tissue is affected by the cancer treatment.

According to another aspect of the invention, an amplifier array, inconjunction with the processor, can focus energy in any area within themass (to create a “hot zone”). This is done by proportionally varyingthe voltage amplitude and pulse-widths between electrodes to dynamicallyand proportionally shift, steer, or create a “hot zone” anywhere in themass in three dimensions. The surgeon can focus on specific areas withinthe mass to ensure destruction of all cancerous cells. This supplies thesurgeon with yet another tool to physically destroy all malignant orbenign cells.

In another aspect of the invention, a processor will start the treatmentprotocol by slowly ramping the voltage and current up to a level, forexample, in the milliampere range, where the surgeon can verify that allamplifiers are conducting current as specified to achieve the desiredtemperatures. The thermal sensors provide data for the processor so thesoftware commands can make adjustments to the amplifier drive voltageamplitudes and pulse-widths. The goal is to uniformly elevate the massto a temperature of from about 48° C. to about 50° C., for from about 5to about 10 minutes or until all malignant or benign cells within themass are destroyed.

The time to heal from this procedure should be from a few days to abouttwo weeks or so, at which point MRI, CT, and/or ultrasound scans can beemployed to analyze the area of interest and verify that the mass hasbeen destroyed. In addition to the quick healing time, an advantage tothis treatment is that unlimited additional treatments may be made to“touch up” any cells that were missed during the initial treatment.Furthermore, no damaging radiation or chemotherapy would be required toaffect the cure, and there would be no migration of cells due tosurgical intrusion.

In another aspect of the invention, a processor is used to drive apreamplifier and amplifier which dynamically and proportionally steercurrent vectors between specially-designed electrodes on shafts insertedstrategically around the mass in an infinite variety of waveforms whichinclude, but are not limited to, arbitrary waveforms of any shape,amplitude or pulse-width using direct current (DC) and/or alternatingcurrent (AC) and frequencies of AC up to about 1 KHz of voltage,dependent upon the situation/mass and the treatment required. Thesurgeon can use the processor to vary the voltage amplitude, currentintensity, and/or pulse-width and select any arbitrary waveform to heatand maintain thermal averaging throughout the entire targeted mass to anequal temperature sufficient to destroy the offending cells in situ. Theenergy can also be used to include a perimeter hyperthermia zone aroundthe mass in three dimensions to ensure all microscopic cancerous cellsare captured in the treatment.

In another aspect of the invention, a method is described to delivermonophasic and biphasic ascending or descending exponential, ramp ordamped sinusoidal waveforms which are most efficient with respect toheating a cancerous or benign mass by using an amplifier array where anythree or more amplifiers and their respective electrodes may be drivendifferentially as to draw current through selected current pathways ordifferent angular perspectives within the cancerous mass. Also, any oneamplifier may be driven differentially to any of the other amplifiers inthe array sequentially and/or simultaneously using the same arbitrarywaveform or any amplifier may be driven differentially to any of theother amplifiers sequentially using different arbitrary waveforms atdifferent or equal voltage and current amplitudes. By use of thisapproach, many combinations of electrical current deliveries arepossible and can be selected by the surgeon based upon individualpatient requirements for tumor destruction within a three dimensionalconstruct.

In another aspect of the invention, the amplifiers will process anywaveform and voltage amplitude through the mass as directed and selectedby the surgeon, such as ascending or descending exponential, ramp,damped sine, square, sine, triangle, saw tooth, etc. The voltageamplitude range shall be from about 0 to about +/−200V.

In another aspect of the invention, a method of treating massescomprises dynamically and proportionally steering or selecting two ormore current vector paths sequentially or simultaneously for celldestruction.

In another aspect of a method of the invention, the method is carriedout with differentially driven amplifiers, rather than a single currentpath or using the devices that deliver current and energy across two ormore current pathways, but that cannot dynamically and proportionallyalter the voltage and current amplitude through each pathway.

In another aspect of the invention, a method can treat masses in hard orsoft tissues.

In another aspect of the invention, a method of treating massescomprises delivering biphasic ascending or descending exponential, rampor damped sinusoidal waveforms which are most efficient with respect tothe cell conduction by using an amplifier array where any two, three, ormore amplifiers and their respective electrodes may be drivendifferentially and proportionally as to draw current through selectedcurrent pathways or different angular perspectives with the mass.

In another aspect of a method or apparatus of the invention, any oneamplifier may be driven differentially to any of the other amplifierssequentially and/or simultaneously using the same arbitrary waveform.Alternatively, any one amplifier may be driven differentially to any ofthe other amplifiers sequentially and/or simultaneously using individualand different arbitrary waveforms at different or equal voltage andcurrent amplitudes.

In another aspect of a method of the invention, a positive pulse may usea square wave and a negative pulse may use a ramp waveform, or anywaveform shape. This allows the plus and minus waveform shapes to bemixed and matched to achieve optimum treatment results.

In another aspect of a method of the invention, the surgeon can selectpre-programmed and pre-defined software waveform protocols, wherein manycombinations of current deliveries are possible based on individualpatient requirements for destruction of cancer cells.

In another aspect of a method of the invention, the individualrequirements are selected from the software protocol based on variousmedical criteria as defined by the surgeon.

In another aspect of a method or apparatus of the invention, waveformprotocols are pre-programmed and pre-defined and are loaded into aprocessor memory for quick execution.

In another aspect of a method or apparatus of the invention, 100 or moreprotocols can be stored for a surgeon to select from the computer menu.

In another aspect of a method or apparatus of the invention, arbitrarywaveforms can be delivered to multiple electrode configurations, andmultiple sequential or simultaneous 3-dimensional current paths can beemployed.

In another aspect of a method or apparatus of the invention, theamplifiers will process any waveform through the mass directed by asurgeon such as ascending or descending exponential, damped sine, ramp,square, sine, triangle, ramp or saw tooth, in DC or AC positive ornegative pulses.

In another aspect of a method or apparatus of the invention, monophasicor biphasic sequential or simultaneous current pulses are in the rangeof from about Oms to about 10s positive and negative time periods,respectively.

In another aspect of the invention, an apparatus for destroying massescomprises means for dynamically and proportionally current steering orselecting two or more current vector paths sequentially orsimultaneously through an amplifier and electrode delivery system forcell destruction.

In another aspect of the invention, the apparatus accomplishes itspurpose by dynamic and proportional current steering rather than usingtraditional devices which destroy partial masses using single currentpath or devices that deliver energy across two or more current pathways,but that cannot dynamically and proportionally alter the voltage,current amplitude and current pulse-widths through each pathway.

In another aspect of an apparatus of the invention, any one amplifiermay be driven differentially to any of the other amplifierssimultaneously using the same arbitrary waveform. Alternatively, any oneamplifier may be driven differentially to any of the other amplifierssequentially using individual or different arbitrary waveforms atdifferent or equal voltage and current amplitudes, as well as varyingpulse-widths to a achieve desired temperatures.

In another aspect of the invention, the possibility of cancerous orother cells from the mass breaking free and migrating to other areas ofthe body during the surgical process is eliminated. It also allows themass to convert to scar tissue which can be left in place, or removed ata later time. The current pulses are kept within the radius of theelectrode perimeters via dynamic and proportional current steering ascommanded via the processor so that a minimum of healthy tissue isaffected by the treatment.

In another aspect of the invention, electrode shafts will be designedsuch that the surgeon can easily see the difference between the platinumbands and the electrode shafts using existing ultrasound equipment. Thisfacilitates the alignment of the electrodes relative to the mass ofinterest in three dimensions.

In another aspect of the invention, a method of treating a mass within apatient's body comprises dynamically and proportionally steering currentvectors through the mass to heat the mass.

In another aspect of the invention, a method of treating a conditionwithin a patient's body comprises dynamically and proportionallysteering current vectors to a predetermined defined area to resistivelyheat the defined area to alleviate the condition.

In another aspect of a method of the invention, three or more shaftscomprising at least two electrodes on each shaft are positioned aroundthe mass and voltages applied to the electrodes are varied todynamically and proportionally steer current vectors through the mass ordefined area.

In another aspect of a method of the invention, three shafts are usedand each shaft has three electrode bands.

In another aspect of a method of the invention, the mass is heatedsufficiently to destroy or inactivate all of the cells within the mass.

In another aspect of a method of the invention, a processor-controlledelectronic amplifier array generates signals to produce dynamically andproportionally steered current vectors under software control using acomputer.

In another aspect of a method of the invention, the processor managesthe voltage, current, pulse-widths, arbitrary waveforms and thermal dataand makes adjustments to the amplifier drive voltage amplitudes.

In another aspect of a method of the invention, an ascending ramp willgenerate a rate of change slower than the leading edge of a squarewaveform.

In another aspect of a method of the invention, the current vectorscreate a hot zone within a mass or defined area which is the summationof intersecting current vectors to induce hyperthermia.

In another aspect of a method of the invention, the current vectorsuniformly elevate the mass to a temperature of from about 48° C. toabout 50° C. until all malignant cells within the mass are destroyed.

In another aspect of a method of the invention, the mass is a cancerousor benign mass.

In another aspect of a method or system of the invention, the definedarea is within the patient's prostate gland.

In another aspect of a method of the invention, the mass is prostatecancer or breast cancer.

In another aspect of the invention, a system for treating a condition ormass within a patient's body comprises:

three or more electrode shafts, each having at least two electrodespositioned along the shaft;

a processor for generating instructive signals;

an amplifier for receiving instructive signals from the processor andgenerating signals to the electrodes,

wherein voltages of the electrodes are varied to dynamically andproportionally steer current vectors to and through the mass toresistively heat the mass or area to treat a condition.

In another aspect of a system of the invention, the processor containsprotocols to permit a surgeon to select a particular protocol.

In another aspect of a system of the invention, the system comprisesthree electrode shafts, each electrode shaft having two or more platinumbands or contact points.

In another aspect of a system of the invention, each electrode shaft hasa small insertion diameter.

In another aspect of a system of the invention, each electrode has athermal sensor.

In another aspect of a system of the invention, each electrode shaft hasa distal tip with a coating or substrate comprising a dissolvable saltcompound.

In another aspect of a system of the invention, each electrode shaft hasone or more inflatable components that can be inflated to provide formechanical stability while surrounding defined area such as a cancerousor benign mass.

In another aspect of a system of the invention, the system is suitablefor treating masses which occur in the prostate, breast, liver, lungs,brain, pancreas, kidneys, uterus, skin, or ovaries.

In another aspect of a system of the invention, each electrode shaftcomprises a cooling system to dynamically cool the electrode duringtreatment.

In another aspect of a system of the invention, the processor managesthe voltage, current, pulse-widths, arbitrary waveforms and thermal dataand makes adjustments to the amplifier drive voltage amplitudes.

In another aspect of a system of the invention, an ascending ramp willgenerate a rate of change slower than the leading edge of a squarewaveform.

In another aspect of a system of the invention, by using an amplifierarray in conjunction with a processor, energy can be focused in anyspecific area within a mass by proportionally varying the voltageamplitude and pulse-widths between electrodes to dynamically shift orsteer a hot zone anywhere in the mass in three dimensions, withoutmoving the amplifier electrodes, to ensure destruction of all cancerousor malignant cells.

In another aspect of a system of the invention, the materials andconstruction of the electrode shafts and electrodes will be such thatthe difference between the electrodes and the electrode shafts will bereadily apparent by use of conventional ultrasound equipment.

In another aspect of a method of the invention, a method of treating amass within a patient's body comprises dynamically and proportionallysteering current vectors around the perimeter of a mass to destroy thevasculature which feeds nutrients and blood supply to the mass.

In another aspect of a method of the invention, a method of treating amass in a patient's body comprises the steps of:

inserting two or more biopsy probes or needles into a patient todetermine the extent of a mass, and

dynamically and proportionally steering current vectors through the massto heat the mass.

In another aspect of a method of the invention, the biopsy probes orneedles are removed before electrode shafts are inserted into thepatient.

In another aspect of a method of the invention, the biopsy probes orneedles are inserted into an organ.

In another aspect of a method of the invention, the organ is a prostateor a breast.

In another aspect of the invention, biopsy probes or needles are capableof functioning as electrode shafts having two or more electrodes.

In another aspect of the invention, a system for treating a mass withina patient's body comprises:

three or more electrode shafts that define an area, each shaft having atleast two electrode bands positioned along the shaft;

a processor configured to generate instructive signals that are DCarbitrary waveforms or AC arbitrary waveforms of a frequency of up toabout 1 KHz; and

an amplifier array configured to receive instructive signals from theprocessor and to deliver signals to the electrode bands,

wherein the processor is configured to control the amplifier array insuch a way as to proportionately vary the voltage amplitude of signalsto the electrode bands to dynamically steer and focus ionic currentvectors to create and steer a hot zone anywhere in three dimensionswithin the area between the electrode shafts, without moving theelectrodes, to resistively heat the mass to ensure destruction of allmalignant or benign cells.

In another aspect of a system of the invention, the processor containspre-programmed protocols to permit a medically trained operator toselect a particular protocol for treating a mass.

In another aspect of a system of the invention, each electrode shaft hastwo or more platinum bands or contact points as electrode bands.

In another aspect of a system of the invention, each electrode shaft hasan insertion diameter of from about 0.9 mm to about 5 mm.

In another aspect of a system of the invention, each electrode shaft hasa distal tip with a dissolvable coating or substrate.

In another aspect of a system of the invention, each electrode shaft hasone or more inflatable components that can be inflated to providemechanical stability while surrounding a malignant or benign mass beingtreated.

In another aspect of the invention, a system is suitable for treatingmalignant or benign masses which occur in a breast, liver, lungs, brain,pancreas, uterus, prostate, skin, or ovary or elsewhere within apatient's body.

In another aspect of a system of the invention, each electrode shaftcomprises a cooling system to dynamically cool the electrode bandsduring treatment.

In another aspect of a system of the invention, the processor samplesand analyzes thermal data from the thermal sensors and manages theamplifier-delivered energy by adjusting voltage amplitudes andpulse-widths of waveforms delivered to the electrode bands.

In another aspect of a system of the invention, the materials andconstruction of the electrode shafts and electrode bands will be suchthat visual surface contrasts of the electrode shafts and the electrodebands can be differentiated by a medically trained operator usingconventional ultrasound or other imaging equipment.

In another aspect of a system of the invention, all the ionic currentvectors combine to generate controlled and focused hyperthermia.

In another aspect of the invention, a system is configured toelectronically steer the ionic current vectors to uniformly elevateareas of the mass to a temperature of from about 48° C. to about 50° C.,until all malignant or benign cells within the mass are neutralized sothat further abnormal cell growth cannot occur.

In another aspect of a system of the invention, a system furthercomprises a grid block, wherein three or more electrode shafts withelectrode bands will be capable of being inserted into holes within thegrid block while an ultrasound video is used simultaneously as amechanical guide to surround the malignant or benign mass.

In another aspect of the invention, a system for treating a mass withina patient's body comprises:

three or more electrode shafts that define an area, each shaft having atleast two electrode bands positioned along the shaft;

a processor configured to generate instructive signals that are DCarbitrary waveforms or AC arbitrary waveforms of a frequency of up toabout 1 KHz; and

an amplifier array configured to receive instructive signals from theprocessor and to deliver signals to the electrode bands,

wherein the processor is configured to control the amplifier array insuch a way as to proportionately vary the voltage amplitude of signalsto the electrode bands to dynamically steer and focus ionic currentvectors to create and steer a hot zone anywhere in three dimensionswithin the area between the electrode shafts and around the perimeter ofthe mass using a fencing technique, without moving the electrodes, todestroy vasculature which feeds nutrients and blood supply to the massby resistive heating.

In another aspect of the invention, a system for treating a malignant orbenign mass within a patient's body which comprises three or moreelectrode shafts that define an area, each shaft having at least twoelectrode bands positioned along the shaft, a computerprocessor-controlled electronic amplifier array which is configured todeliver signals that are DC arbitrary waveforms or AC arbitrarywaveforms of a frequency of up to about 1 KHz to the electrode bands,wherein the computer-controlled processor is configured to control theamplifier array in such a way as to proportionately vary the voltageamplitude of signals to the electrode bands to dynamically steer andfocus ionic current vectors to create and steer a hot zone anywhere inthree dimensions within the area between the three or more electrodeshafts, without moving the electrodes, and wherein the mass isresistively heated sufficiently to neutralize all abnormal cells withinthe mass while minimizing damage to surrounding healthy tissue.

In another aspect of a system of the invention, each electrode shaft hasat least one thermal sensor to provide feedback to the processor.

In another aspect of a system of the invention, the temperatures of thethermal sensors are monitored and the current delivered to eachelectrode band is monitored.

In another aspect of a system of the invention, the combination ofthermal and current measurements is fed into an algorithm the processoruses to vary the voltage amplitude.

In another aspect of a method of the invention for treating a masswithin a patient's body, the method comprises:

positioning three or more electrode shafts that define an area around amass, each shaft having at least two electrode bands positioned alongthe shaft;

generating instructive signals from a processor that are DC arbitrarywaveforms or AC arbitrary waveforms of a frequency of up to about 1 KHz;and

receiving the instructive signals from the processor in an amplifierarray configured to receive such signals and to deliver signals to theelectrode bands,

wherein the processor is configured to control the amplifier array insuch a way as to proportionately vary the voltage amplitude of signalsto the electrode bands to dynamically steer and focus ionic currentvectors to create and steer a hot zone anywhere in three dimensionswithin the area between the electrode shafts, without moving theelectrodes, to resistively heat the mass to ensure destruction of allmalignant or benign cells.

In another aspect of a method of the invention, each electrode shaft hasthree electrode bands.

In another aspect of a method of the invention, the processor-controlledelectronic amplifier array generates signals to dynamically andproportionally steer current vectors under software control using acomputer.

In another aspect of a method of the invention, the processor managesthe voltage, current, pulse-widths, arbitrary waveforms and thermal dataand makes adjustments to the amplifier drive voltage amplitudes.

In another aspect of a method of the invention, the method comprises theadditional step of:

inserting two or more biopsy probes or needles into a patient's organ todetermine the extent of a mass.

In another aspect of a method of the invention, the biopsy probes orneedles are removed before electrode shafts are inserted into thepatient.

In another aspect of a method of the invention, biopsy probes or needlesare capable of functioning as electrode shafts having two or moreelectrode bands.

In another aspect of a method of the invention, the processor containspre-programmed protocols to permit a medically trained operator toselect a particular protocol for treating a mass.

In another aspect of a method of the invention, each electrode shaft hastwo or more platinum bands or contact points as electrode bands.

In another aspect of a method of the invention, each electrode shaft hasa distal tip with a dissolvable coating or substrate.

In another aspect of a method of the invention, each electrode shaft hasone or more inflatable components that can be inflated to providemechanical stability while surrounding a malignant or benign mass beingtreated.

In another aspect of a method of the invention, malignant or benignmasses which occur in a breast, liver, lungs, brain, pancreas, uterus,prostate, or ovary or elsewhere within a patient's body are treated.

In another aspect of a method of the invention, each electrode shaftcomprises a cooling system to dynamically cool the electrode bandsduring treatment.

In another aspect of a method of the invention, each electrode shaft hasat least one thermal sensor to provide feedback to the processor.

In another aspect of a method of the invention, the processor samplesand analyzes thermal data from the thermal sensors and manages theamplifier-delivered energy by adjusting voltage amplitudes andpulse-widths of waveforms delivered to the electrode bands.

In another aspect of a method of the invention, the materials andconstruction of the electrode shafts and electrode bands will be suchthat visual surface contrasts of the electrode shafts and the electrodebands can be differentiated by a medically trained operator usingconventional ultrasound or other imaging equipment.

In another aspect of a method of the invention, all the ionic currentvectors combine to generate controlled and focused hyperthermia.

In another aspect of a method of the invention, the ionic currentvectors are steered to uniformly elevate areas of the mass to atemperature of from about 48° C. to about 50° C., until all malignant orbenign cells within the mass are neutralized so that further abnormalcell growth cannot occur.

In another aspect of a method of the invention, three or more electrodeshafts with electrode bands will be capable of being inserted into holeswithin a grid block while an ultrasound video is used simultaneously asa mechanical guide to surround the malignant or benign mass.

In another aspect of the invention, a method for treating a mass withina patient's body comprises:

positioning three or more electrode shafts that define an area around amass, each shaft having at least two electrode bands positioned alongthe shaft;

generating instructive signals from a processor that are DC arbitrarywaveforms or AC arbitrary waveforms of a frequency of up to about 1 KHz;and

receiving instructive signals from the processor in an amplifier arrayconfigured to receive such signals and to deliver signals to theelectrode bands,

wherein the processor is configured to control the amplifier array insuch a way as to proportionately vary the voltage amplitude of signalsto the electrode bands to dynamically steer and focus ionic currentvectors to create and steer a hot zone anywhere in three dimensionswithin the area between the electrode shafts and around the perimeter ofthe mass using a fencing technique, without moving the electrodes, todestroy vasculature which feeds nutrients and blood supply to the massby resistive heating.

In another aspect of a method of the invention, each electrode shaft hasat least one thermal sensor to provide feedback to the processor.

In another aspect of a method of the invention, a predefined area andpercentage of volume within a patient's prostate is treated for BPHusing 3 or 4 electrode shafts whereby the entire volume of tissue withinthe energy field defined by the electrodes is heated using the system asdefined herein to systematically heat the area defined to destroy orinactivate the cells contained within the defined area, thereby causingthe area to scar down or atrophy or to soften or otherwise lose its hightensile tone, which in turn reduces pressure on the urethra for thepurpose of alleviating symptoms of BPH, without the use of prescriptiondrugs or surgery.

In another aspect of a system of the invention for treating a mass ormedical condition external or transcutaneous on a patient's body, thesystem comprises:

three or more electrode transcutaneous patches that define an area, eachpatch having a geometry that is consistent with the area of skin and adepth of tissue or mass that is to be treated

a processor configured to generate instructive signals that are DCarbitrary waveforms or AC arbitrary waveforms of a frequency of up toabout 1 KHz; and

an amplifier array configured to receive instructive signals from theprocessor and to deliver signals to the electrode bands,

wherein the processor is configured to control the amplifier array toproportionately vary the voltage amplitude of signals to the electrodebands to dynamically steer and focus ionic current vectors to create andsteer a hot zone anywhere in three dimensions within the defined areabetween the electrode patches in concert with one or more subcutaneouselectrodes to resistively heat the defined area to alleviate thecondition.

In another aspect of the invention, a method of treating a volume ofskin such as a melanoma comprises treating the skin and/or mass in threedimensions with a system comprising:

three or more electrode transcutaneous patches that define an area, eachpatch having a geometry that is consistent with the area of skin and adepth of tissue or mass that is to be treated

a processor configured to generate instructive signals that are DCarbitrary waveforms or AC arbitrary waveforms of a frequency of up toabout 1 KHz; and

an amplifier array configured to receive instructive signals from theprocessor and to deliver signals to the electrode bands,

wherein the processor is configured to control the amplifier array toproportionately vary the voltage amplitude of signals to the electrodebands to dynamically steer and focus ionic current vectors to create andsteer a hot zone anywhere in three dimensions within the defined areabetween the electrode patches in concert with one or more subcutaneouselectrodes to resistively heat the defined area to alleviate thecondition, to induce hyperthermia.

These and other objects, features, and characteristics of the presentinvention, as well as the methods of operation and functions of therelated elements of structure and the combination of parts and economiesof manufacture, will become more apparent upon consideration of thefollowing description and the appended claims with reference to theaccompanying drawings, all of which form a part of this specification,wherein like reference numerals designate corresponding parts in thevarious figures. It is to be expressly understood, however, that thedrawings are for the purpose of illustration and description only andare not intended as a definition of the limits of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic representation of one embodiment of a systemuseful according to the invention;

FIG. 2 is a detailed schematic representation of an aspect of a systemaccording to the invention;

FIG. 3 represents a partial schematic of a differential amplifier arrayuseful according to the invention;

FIG. 4 is a schematic representation of one example of dynamic andproportional current steering according to the invention;

FIG. 5 is a schematic representation of use of a system according to theinvention in treating a mass in a patient's prostate;

FIG. 6A is a representation of a traditional electrical current deliverybetween a plurality of electrodes that do not dynamically orproportionally steer electrical currents;

FIG. 6B is a representation of an example of electrical current deliverybetween a plurality of electrodes that dynamically and/or proportionallysteer electrical currents in three dimensions for the purpose ofcreating hyperthermia in a mass with 100% coverage and no zones ofunwanted cells missed by the treatment;

FIG. 6C sets forth schematic representations (i) to (vi) of dynamic andproportional steering of current among and between three electrodes;

FIGS. 7A and 7B are schematic representations in un-inflated andinflated states, respectively, of an inflatable electrode for treatingcancerous or benign masses in human or mammal organs such as breastcancer or cancer in any other organ accessible by the system;

FIG. 8 is a schematic representation of a “Macro Prostate” treatmentwhere the entire prostate gland is heated as to destroy the entireprostate gland while simultaneously protecting the rectal and urethrabiologic structures via dynamically cooling of the electrodes; and

FIG. 9 is a schematic representation of shafts that have been insertedinto a mass to sequentially map and treat the mass.

DETAILED DESCRIPTION OF THE INVENTION

As used herein, the singular form of “a”, “an”, and “the” include pluralreferences unless the context clearly dictates otherwise. As usedherein, the statement that two or more parts or components are “coupled”shall mean that the parts are joined or operate together either directlyor indirectly, i.e., through one or more intermediate parts orcomponents, so long as a link occurs. As used herein, “directly coupled”means that two elements are directly in contact with each other. As usedherein, “fixedly coupled” or “fixed” means that two components arecoupled so as to move as one while maintaining a constant orientationrelative to each other.

As used herein, the word “unitary” means a component is created as asingle piece or unit. That is, a component that includes pieces that arecreated separately and then coupled together as a unit is not a“unitary” component or body. As employed herein, the statement that twoor more parts or components “engage” one another shall mean that theparts exert a force against one another either directly or through oneor more intermediate parts or components. As employed herein, the term“number” shall mean one or an integer greater than one (i.e., aplurality).

Directional phrases used herein, such as, for example and withoutlimitation, top, bottom, left, right, upper, lower, front, back, andderivatives thereof, relate to the orientation of the elements shown inthe drawings and are not limiting upon the claims unless expresslyrecited therein.

As employed herein, the statement that two or more parts or components“engage” one another shall mean that the parts exert a force against oneanother either directly or through one or more intermediate parts orcomponents.

As employed herein, the term “number” shall mean one or an integergreater than one (i.e., a plurality).

By definition, electrolysis of water is the decomposition of water (H₂O)into oxygen (O₂) and hydrogen gas (H₂) due to an electric current beingpassed through the water. An electrolyte is any substance containingfree ions that make the substance electrically conductive. The mosttypical electrolyte is an ionic solution, but molten electrolytes andsolid electrolytes are also possible.

Commonly, electrolytes are solutions of acids, bases or salts. The humanbody is full of electrolyte solutions comprising, calcium, potassium,magnesium, etc., and all will conduct electricity.

If the above-described processes occur in pure water, H⁺ cations willaccumulate at the anode, and OH⁻ anions will accumulate at the cathode.The negative hydroxyl ions that approach the anode mostly combine withthe positive hydronium ions (H₃O⁺) to form water. The positive hydroniumions that approach the negative cathode mostly combine with negativehydroxyl ions to form water. Relatively few hydronium (hydroxyl) ionsreach the cathode (anode). This can cause a concentration over-potentialat both electrodes.

This is applicable to the present invention. Dynamic and proportionalcurrent steering can be applied through an ionic solution or ionic mass.With regard to electrical currents, there are two basic conductionmethods. First, electrons flow through conductive metals such as copper,silver, gold, steel, aluminum, etc. If alternating current (AC) isapplied, the current flow will be positive to negative and negative topositive, alternating at the selected frequency between electrodes whichbecome anodes and cathodes alternating respectively. With direct current(DC), through a conductive metal, electrons flow from negative topositive with the cathode being the negative and the anode being thepositive. Current will only flow in one direction, and it is notalternating.

The second major category is electrical currents through an ionicsolution or ionic mass. If an electrical current is applied between twoconductive electrodes while in distilled water or de-ionized water,little or no current will flow, whether AC or DC is applied. However, ifone adds an ionic element or electrolyte solution into the distilled orde-ionized water, such as sodium, potassium, calcium, etc., orhomogenizes them into a solid mass, they now become electricallyconductive, but not in the same way as the electron flow describedabove.

For example, if two electrodes which are electrically conductive areplaced in a salt-water solution, and a direct current and voltage areapplied of sufficient amplitude, electron current will flow through thewires from the power source such as a battery or power supply to andfrom the electrodes. However, electrons cannot flow between theelectrodes in the ionic solution. What occurs at each electrode in anionic solution or mass is a chemical reaction between the electroncarrying electrodes to and from the electrodes and the ionic solution ateach electrode. One electrode is an anode which is positive, and oneelectrode is a cathode which is negative when using direct current (DC).

If one was to map and measure the current and energy field between theelectrodes, it would become apparent quickly that there is a currentdensity which is represented in an elliptical shape between the twoelectrodes. Within the ellipse, the current density will be most intensein a straight line between electrodes positive and negative in thesolution or mass, that is, basically, the path of least resistance.

Medically, if an electrolyte such as a salt as added into pure water,the result is an ionic solution. When electrical energy is appliedbetween two electrodes, it is electrons that are flowing, but only tothe point where it is converted into a chemical reaction at theinterface between the electrodes and the ionic solution or ionic masswhere the energy is converted into ionic current.

An important characteristic of the invention described and claimedherein is that heat is generated between any two or more electrodes whenelectrical currents are applied. The challenge is to control the currentvectors or paths to create heating or hyperthermia in the desired areassufficient to destroy cancer cells. The preferred control percentage interms of the cancerous mass would be 100% coverage.

To achieve a 100% heating or hyperthermia successfully within acancerous or benign mass one must dynamically and proportionally steercurrents between several electrodes in three dimensions to obtain thedesired zones and coverage of hyperthermia. To dynamically andproportionally steer electrical currents through an ionic mass, one mustadd at least a third electrode and perhaps several electrodes to achievethe control required to destroy cancer cells and masses within the 3Dconfines of a human or mammal's organs. For example, if three electrodes1, 2, 3 are equally spaced in a glass container 120° apart, and a directcurrent and voltage of +100V to is applied to electrode 1 and −100V isapplied to each of the other two electrodes 2 and 3, the result will bean elliptical pattern of current between not only electrodes 1 and 2,but also between electrodes 1 and 3. There will be an ionic current flowin each of two directions with equal current densities. Both paths willgenerate heat or hyperthermia.

Further, if both voltages are of equal potential, there will be twoelliptical patterns in two different directions. If it is desired tosteer the current between electrodes 1 and 2 and electrodes 1 and 3, onewould lower the voltage on electrode 2 and increase the voltage onelectrode 3. The current density between electrodes 1 and 2 will not beequal to the current density between electrodes 1 and 3. The currentdensity will shift such that a lower current density will be presentbetween electrodes 1 and 2, and a higher current density will be presentbetween electrodes 1 and 3. Also, importantly, as the voltage risesbetween selected electrodes, the impedance or resistance within theionic mass will drop and increased current is a result. Thus, by raisingand lowering the voltage output between three or more amplifiers, thecurrents between electrodes will rise and fall as commanded by theprocessor, and, as a result, increased or decreased heating will occurin the areas selected for treatment. Increased current results inincreased heating.

If one wishes to dynamically and proportionally steer current through anionic solution in 360°, all three electrodes will be used. This dynamicand proportional steering is accomplished by varying the voltages andcurrents between all three electrodes at varying voltages and currentintensities and rates of change among all three electrodes as commandedthrough the amplifier array via the processor and computer commands.Now, instead of discrete elliptical current patterns and densitieswithin the construct of this 360° ionic solution, there will be ahomogenized and an equal hyperthermia pattern or a focused hyperthermiapattern may be created via the amplifier array and itscomputer-controlled commands. Not only can the hyperthermia patterns beradial, they may also be vertical or at any angular perspective desiredto produce the desired hyperthermia within a 3D domain.

The rate of change or time it takes to increase or decrease the currentdensity between electrodes 1 and 2 while transitioning to a higher orlower current density between electrodes 1 and 3 is a function of therates of change in terms of time with respect to the rate of change ofvoltage and current it determines how fast the steering occurs. This iswhere having the capability to deliver arbitrary waveforms issignificant. An ascending ramp will generate a rate of change slowerthan the fast leading edge of a square waveform.

If you have three amplifiers driven dynamically and proportionally usingalternating or direct current, one can vary the amplitude of the voltagebetween electrodes 1 and 2 and electrodes 1 and 3 in a proportionalfashion to lower the voltage between electrodes 1 and 2 whilesimultaneously raising the voltage between 1 and 3. As a result, theelliptical patterns become blended or homogeneous within the ionicsolution or mass of interest and dynamic, proportional steering willoccur.

If this is taken a few steps further, consider using three platinum bandelectrodes per electrode shaft in the same 120° scenario, with a volumeof salt water, a depth, a diameter, and electrolyte ionic solution. Withuse of processor commands and a computer, arbitrary waveforms can bedelivered with nine definitive electrode bands with a vertical span,circumference, or radius and depth. We now have the ability to controlwhat is known as six degrees of freedom, including pitch, yaw, and roll.If these simple principles are applied using complex circuitry andsoftware commands, and it is now possible to have 72 vectors of energyin the form of an ionic current flowing through a mass in threedimensions. In a more granular system, there may be 12 or more activeelectrode bands or 132 or more vectors of energy, all of which can beenergized in all vectors point-to-point, but they can also all besteered dynamically and proportionally by raising and lowering voltageand current amplitudes between all of the electrodes as commanded by thesoftware and processor. There are two modes of operation: the system canbe programmed to uniformly heat the solution or mass within the confinesof the electrode amplifier array, or a focal “hot zone” or zone of heatthat is more intense collectively than a generalized heated area can beproduced. An analogy would be a magnifying glass in the sun. You canfocus it on a piece of paper and the paper will burn. But if you takethree magnifying glasses and focus them on the same point, you will getconsiderably more energy focused on the one point. If you want to movethat optically heated point to a different location, you would simplytilt the lenses slightly in unison, to move the “hot zone.”

The same thing is true with dynamically and proportionally steeringcurrent through an ionic mass. You can focus the energies of all nine ormore electrodes at a targeted position, or you can steer currents insuch a fashion as to raise and lower the temperature at will, or one maywish to induce thermal averaging and hold a specific temperature untilthe mass of interest is destroyed. Software commands the processor,which commands the preamplifier, which commands the amplifiers whichdeliver the voltage and current in sufficient energy levels between theelectrodes as to create heat or induce hyperthermia, a byproduct ofdrawing current through an ionic solution or mass.

The ability to control energy in the form of heat, which is a byproductof drawing voltage and current between several electrodes using softwarecommands through amplifiers which supply a proportional ability to raiseand lower voltage, allows the surgeon to heat any area of a mass withoutrelocating the electrode shafts, the use of radiation or chemotherapyfor the treatment of a cancerous or benign masses.

FIG. 1 is a schematic overview illustrating an oncology treatment systemaccording to the present system. A system 2 comprises a computer 4 suchas a laptop that provides the software waveforms and intelligentcommands that direct a processor 6 which further processes commands fromcomputer 4 to define and deliver the appropriate waveforms. Suchwaveforms include voltage amplitude, arbitrary waveforms, peak currentsand other electrical attributes which are then converted withinprocessor 6 from digital to analog signals. The analog signals are thendelivered to a preamplifier 10 which provides a small voltage gain inamplitude so that the waveforms selected for treatment can bedistributed and delivered into an amplifier 12, which then providesvoltage and current amplification at much higher levels. That allows forvoltage and current waveforms to be delivered through the proximal endof a common multi-conductor cable 14, which is of a sufficient length toreach from an equipment rack (not shown) to a patient (not shown).Computer 4 contains a user friendly menu so the surgeon may select whichprotocol he or she needs to destroy cancerous masses.

Cable 14 has a distal end 16 that is electrically connected to theproximal ends 32, 34, 36 of three cylindrical electrode shafts 18, 22,24. Each electrode shaft 18, 22, 24 has at least three platinumelectrode bands, identified here as bands B1 to B9. Each electrode shaft18, 22, 24 has at its distal end a rigid dissolvable salt coating orsubstrate 28, to aid the surgeon with insertion into the patient. Suchcoating or substrate 28 will comprise a physiologically acceptable saltsuch as sodium chloride, potassium chloride, calcium chloride, or afunctional equivalent. The coating or substrate 28 will partially orwholly dissolve during use, that is, after insertion into a patient'sbody.

At least the external surface of each electrode shaft 18, 22, 24, if notthe entire shaft, comprises a rigid or substantially rigidnon-conductive, sterilizable, and physiologically and medicallyacceptable material such as a polyethylene, polycarbonate, orpolyurethane polymer or copolymer. The size of electrode shafts 18, 22,24 can vary according to intended use and/or the size of the mass to betreated. For example, electrode shafts 18, 22, 24 could be from about 10cm to about 40 cm, preferably from about 15 cm to about 30 cm, in lengthand from about 0.9 mm to about 5 mm, preferably from about 1 mm to about2.5 mm, in diameter. Electrode bands B1 to B9 are spaced from about 2 cmto about 4 cm, preferably from about 2.5 to about 3.5 cm, apart, with awidth of from about 0.5 cm to about 5 cm, preferably from about 1 cm toabout 4 cm.

FIG. 2 is a detailed illustration of the system 2 shown in FIG. 1 whereamplifier 12 from FIG. 1 comprises an array 30 of nine amplifiers A1 toA9, based upon three electrode shafts having three platinum electrodebands each, which amplifiers A1 to A9 amplify the signals into electrodeshafts 18, 22, 24 and corresponding electrode bands B1-B9. If the threeelectrode shafts each had four electrode bands, there would be twelveamplifiers A1 to A12. Three or four electrode bands on each shaft areconsistent with 9 to 12 amplifiers, although nine amplifiers is theoptimal and typical system.

As illustrated, computer 4 sends digital signals to processor 6 and theninto preamplifier 10, which distributes signals from processor 6 into asmany preamplifier 10 output signals as are required for proper treatmentof a malignant or benign mass 40.

The processor interprets the commands received from the computer andgenerates arbitrary waveforms of any shape, amplitude and pulse widthswhich are required to drive the amplifier array. Also, the processorconverts the digital waveform information into analog waveform signalsusing a digital to analog converter. The analog waveform is amplified bythe preamplifier. The preamplifier also serves as an electronic platformto mix and blend waveform signals prior to sending them onto the poweramplifiers which make up the amplifier array as well as for thermalregulation and monitoring the current in each amplifier that makes upthe array used for treatment.

Preamplifier 10 is required for two basic functions: First, it takesvery small voltage signals and amplifies them to a level where a poweramplifier array can be driven to the appropriate voltages and currentswhich are required to treat the cancerous or benign masses of interest.And second, the preamplifier circuitry also serves as a platform forreceiving the thermal feedback and current data in “real time” andcommunicates with the processor so the software may make minoradjustments to raise and lower voltage amplitudes which affect currentlevels and thus affect thermal control within and around the mass ofinterest. Overall system feedback is important to affect the mostsuccessful medical outcome and for reasons of safety. The preamplifierin concert with the processor monitors all circuit functions so in theevent of a component failure or power failure the system would shutitself down so as not to harm the patient being treated. Another aspectof this safety circuitry is it has the capability to run diagnostics onthe amplifier array and make smart adjustments as required duringtherapy.

Amplifier array 30 comprises 9 to 12 or more amplifiers which are allidentical in terms of circuit architecture. They are designed to deliverany voltage and current required to successfully treat cancerous orbenign masses using voltages from about zero to +/−200V AC or DC. Thevoltage and current will be varied to achieve thermal averaging or afocused thermal zone of hyperthermia as an effective treatment systemfor cancer in a patient. The amplifier array can be configured viasoftware commands to operate in both constant voltage or constantcurrent modes. Ultimately, having total control over heating the canceror benign masses of interest in three dimensions make this a useful toolfor cancer surgeons to increase cure rates among cancer patients.

The figures herein represent an exemplary depiction of three electrodeshafts with three platinum electrode bands for delivering electricalcurrents in a prostate gland within a construct of three dimensions forthe purpose of creating hyperthermia to destroy a cancerous or benignmass. It will be appreciated by those skilled in the art that there canbe more than three electrode shafts, that each electrode shaft can haveat least two, and perhaps as many as 4 to 8 or more electrode bands orcontact points, and that each electrode shaft may not have the samenumber of electrode bands or contact points as another shaft. Further,while a platinum electrode band or contact point is preferred, otherconductive materials, preferably radiopaque, such as nitinol orstainless steel, may be used.

FIG. 3 is a schematic illustration of the design architecture of atypical power amplifier array 30 comprising amplifiers A1-A9 inexemplary fashion. Each amplifier in array 30 differentially drives asignal into one of three electrode shafts 18, 22, 24 containing nineplatinum electrode bands B1-B9. Amplifier array 30 is capable ofdelivering voltages and currents into electrode shafts 18, 22, 24containing platinum electrode bands B1-B9 with an approximate voltageoutput of +/−100V AC or DC, which, when differentially driven, producesfrom about 0 to +/−200V. This proportional voltage and current deliverysystem allows for precise treatment options for the desired outcome ascommanded by the surgeon via the computer 4, processor 6, preamplifier10, and amplifier array 30.

FIG. 4 is a schematic representation of an exemplary application of theamplifiers A1-A9 of array 30 in addition to electrode shafts 18, 22, 24and their corresponding platinum electrode bands B1-B9, all deliveringenergy to and through a cancerous or benign mass 40. As depicted,voltage and current vectors may be delivered in straight lines or may bedynamically and proportionally steered as commanded by the surgeon viathe computer 4, processor 6, preamplifier 10, and array 30 of amplifiersA1-A9.

FIG. 5 illustrates an exemplary application for the treatment of a mass40 within the construct of a prostate gland 42 or any other organ in amale patient or any organ in a female patient. A urethra 44 is depictedas it traverses prostate gland 42 for reference. Electrode shafts 18,22, 24 are inserted into a patient, deep into the prostate gland, forthe purpose of aligning the electrode shafts 18, 22, 24. Correspondingplatinum electrode bands B1-B9 receive signals from cable 14 andamplifiers A1-A9 so as to surround cancerous or benign mass 40 ofinterest in a 3-dimensional (3D) construct. Electrode shafts 18, 22, 24are designed in such a way so as to contrast on ultrasound video todiscriminate between the platinum electrode bands B1-B9 and thenon-conductive, shaft portion of electrode shafts 18, 22, 24. This aidsthe surgeon with the appropriate placement of the electrodes.

FIG. 6A is a schematic representation illustrating an exemplarytwo-dimensional system using electrode shafts 18, 22, 24 and theircorresponding platinum electrode bands B1-B9, where voltages andcurrents are not dynamically or proportionally steered through thecancerous or benign mass 40; rather, straight, point-to-point vectorswill be generated. The nine platinum electrode bands B1-B9 are capableof producing up to 72 vectors; however, using this two-dimensionalsystem, much of mass 40 cannot be subjected to heating or hyperthermia.Therefore, many of the cells contained within mass 40 will not bedestroyed, providing an ineffective treatment.

FIG. 6B is a schematic representation illustrating an exemplarythree-dimensional system using electrode shafts 18, 22, 24 and theircorresponding platinum electrode bands B1-B9, where voltages andcurrents are dynamically and/or proportionally steered as vectors 60through the cancerous or benign mass 40. The nine platinum electrodebands B1-B9 are capable of producing up to 72 vectors 60 using thisthree-dimensional system. Since the voltages and currents aredynamically and/or proportionally steered through mass 40, 100% of mass40 of interest can now be subjected to heating or hyperthermia either ina thermal averaging method or by proportionally commanding electrodeshafts 18, 22, 24 so as to surround mass 40 of interest in athree-dimensional (3D) construct. Another benefit of using thesoftware-commanded system is the ability to create and move an elevatedzone of hyperthermia through mass 40 by applying the principle ofdelivering energy in six degrees of freedom, which representsthree-dimensional heating of mass 40. Therefore, the cells containedwithin mass 40 will be destroyed, providing an effective treatment. Anadditional or optional aspect or benefit of using the three-dimensionalhyperthermia treatment system with dynamic and proportional steering ofcurrent vectors is the ability to surround or “fence” the perimeter of amass 40 with heat three-dimensionally to destroy the vasculature whichfeeds nutrients and blood supply to mass 40.

FIG. 6C comprises schematic cross-sections (i) to (vi) of an exemplarycurrent steering pattern among and between electrode bands B2, B5, andB8 on electrode shafts 18, 22, and 24, respectively. Starting withcross-section (i), as the voltage is commanded to be lowered on B5 byprocessor 4, there is a progressive shift in current flow as depicted incross-section (ii). The current between B2 and B5 begins to decrease,and because there is now a difference in voltage between B5 and B8,current begins to flow between B5 and B8. As the voltage differentialcontinues to decrease between B2 and B5, the current is proportionallysteered through the ionic mass toward B8 as depicted in cross-sections(iii) to (vi). The change in current flow in terms of time or rates ofchange is a function of the commands received from processor 4. If oneapplies this principle of operation to all nine electrode bands, a true3-dimensional cancerous or benign mass may be heated equally or afocused zone of heat may be generated and moved within the mass via theprocessor commands. The current densities are shown with the darkerareas having the higher current densities and the lighter shades havelesser current densities. Thus, voltage and current through an ionicmass generate heat or hyperthermia as follows: Increasingvoltage=increasing current=decreasing impedance=increasing heat.Therefore, dynamic and proportional current steering occurs whenvoltages are raised and/or lowered between electrodes within an ionicsolution or ionic mass.

FIGS. 7A and 7B are schematic representations of an electrode shaft 66which would be ideal for treating masses which occur in the prostate orbreast or organs such as the liver, lungs, brain, pancreas, kidneys,uterus, skin, or ovaries or other masses. In FIG. 7A, electrode shaft 66has platinum electrode bands B1-B3 and deflated, but inflatable,flexible bands or pneumatic bladders 72. In addition, electrode shaft 66has dissolvable rings of salt 74 around platinum electrode bands B1-B3to increase and enhance electrical conductivity. In addition, wires 14to the amplifier array 30, a cooling tube 76 and a thermal sensor 78monitor the temperature of electrode shaft 66 during treatment.

A dissolving salt tip 28 is designed to enable easy insertion into anarea of interest and to minimize or protect against tissue damage afterinsertion.

In FIG. 7B, the pneumatic bladders 72 on electrode shaft 66 have beeninflated to mechanically stabilize electrode shaft 66 in the tissuesurrounding a mass. After the electronic procedure is complete,pneumatic bladders 72 are deflated and electrode shaft 66 is removedfrom the patient.

FIG. 8 illustrates a macro method and apparatus for heating the entireprostate gland 88 in a male patient using dynamic and proportionalcurrent steering and three electrode shafts. A urethral electrode shaft90, having three electrode bands E1, E2, E3, is designed and sized to beinserted into urethra 92 and have a diameter of from about 6 mm to about8 mm, slightly larger than the diameter of a normal urethra or urethralopening. A rectal electrode shaft 100, having three electrode bands E4,E5, E6, is designed and sized to be inserted into rectum 102 and have adiameter of from about 2 cm to about 6 cm, slightly larger than thediameter of a normal rectum. By stretching the construct of urethra 92and rectum 102, the smooth, conformal surfaces of electrode shaft 90,electrode bands E1, E2, E3, electrode shaft 100, and electrode bands E4,E5, E6 are provided with a highly efficient means of electricalconductivity so as to allow current to flow between urethra electrodebands E1, E2, E3 and rectal electrode bands E4, E5, E6. Electrode shafts90 and 100 are dynamically cooled so as not to damage healthy tissue ofthe urethra or rectum. Optionally there may be an inflatable annularring or other structure to stabilize electrode shaft 100 within rectum102.

A third electrode shaft 80 with electrode bands E7, E8, E9 is insertedfrom the bottom into the patient's body at a position out of the planeof electrode shafts 90 and 100. Electrode shaft 80 has a diameter offrom about 1 mm to about 2.5 mm. The length of each of electrodes 80,90, and 100 will be determined by the surgeon according to theapplication. Each of electrode shafts 80, 90, and 100 can be rotated orslid longitudinally to facilitate hyperthermia capture of the entireprostate gland. Electrode shaft 90 should be positioned so thatelectrode band E1 remains within prostate 88 and away from bladder 94 sothat there is not any damage to bladder 94.

FIG. 9 is a schematic representation of a mapping and treatmentprocedure where shafts 80 have been inserted into a mass 82 to map andtreat mass 82. Shafts 80, which can be biopsy probes, needles, or otherlongitudinally extending members that sense parameters or releasechemicals, are typically inserted in predetermined patterns andorientations using a grid plate or template so that the surgeon candetermine the extent, that is, the width, depth, length, and shape, ofmass 82, optionally in concert with the appropriate imaging and scanningdevices. When the extent of a mass is determined, the shafts 80 can bewithdrawn and three or more electrode shafts comprising three platinumbands as electrodes (not shown here) can be inserted to dynamically andproportionally steer current vectors through the mass, as describedabove. Alternatively, some or all of shafts 80 may be a combination ofbiopsy probe or needle and an electrode shaft so that once appropriateimaging and scanning maps and precisely locates a cancerous or benignmass, the mass can be treated using voltages and currents as representedin the present invention stated herein as an “all in one procedure”which is advantageous for the patient. Thus, in accordance with anembodiment of the invention, three or more of shafts 80 comprise two ormore electrode bands so that current vectors can be dynamically andproportionally steered to destroy the mass or masses discovered duringthe mapping procedure.

In the claims, any reference signs placed between parentheses shall notbe construed as limiting the claim. The word “comprising” or “including”does not exclude the presence of elements or steps other than thoselisted in a claim. In a device claim enumerating several means, severalof these means may be embodied by one and the same item of hardware. Theword “a” or “an” preceding an element does not exclude the presence of aplurality of such elements. In any device claim enumerating severalmeans, several of these means may be embodied by one and the same itemof hardware. The mere fact that certain elements are recited in mutuallydifferent dependent claims does not indicate that these elements cannotbe used in combination.

Although the invention has been described in detail for the purpose ofillustration based on what is currently considered to be the mostpractical and preferred embodiments, it is to be understood that suchdetail is solely for that purpose and that the invention is not limitedto the disclosed embodiments, but, on the contrary, is intended to covermodifications and equivalent arrangements that are within the spirit andscope of the appended claims. For example, it is to be understood thatthe present invention contemplates that, to the extent possible, one ormore features of any embodiment can be combined with one or morefeatures of any other embodiment.

What is claimed is:
 1. A method of treating a medical condition within apatient's body, which comprises dynamically and proportionally steeringcurrent vectors to a predetermined defined area to resistively heat thedefined area to alleviate the condition.
 2. The method of claim 1,wherein three or more electrode shafts comprising at least two electrodebands on each shaft are positioned around the defined area and voltagesapplied to the electrodes are varied to dynamically and proportionallysteer current vectors to and through the defined area.
 3. The method ofclaim 2, wherein three electrode shafts are used and each shaft hasthree electrode bands.
 4. The method of claim 1, wherein the definedarea is heated sufficiently to destroy or inactivate cells within thedefined area.
 5. The method of claim 1, wherein the current vectorscreate a hot zone within the defined area which is the summation ofintersecting current vectors to induce hyperthermia.
 6. The method ofclaim 1, wherein the current vectors substantially uniformly elevate thedefined area to a temperature of from about 48° C. to about 50° C. 7.The method of claim 1, wherein the defined area is within a prostategland.
 8. The method of claim 7, wherein the condition treated is BPHand the predefined area and percentage of volume within the prostate istreated using 3 or 4 electrode shafts whereby the entire volume oftissue within the energy field defined by the electrodes is heated tosystematically heat the defined area to destroy or inactivate the cellscontained within the defined area, thereby causing the area to scar downor atrophy or otherwise soften or lose its high tensile tone, which inturn reduces pressure on the urethra to alleviate symptoms of BPH. 9.The method of claim 8, wherein scarring down, atrophy, softening, orloss of high tensile tone of the prostate and alleviation of symptoms ofBPH is accomplished without prescription drugs or surgery.
 10. A systemfor treating a mass or medical condition within a patient's body, whichcomprises: three or more electrode shafts that define an area, eachelectrode shaft having at least two electrode bands positioned along theshaft; a processor for generating instructive signals; and an amplifierfor receiving instructive signals from the processor and generatingsignals to the electrode bands, wherein voltages of the electrodes arevaried to dynamically and proportionally steer current vectors to andthrough the defined area to resistively heat the defined area to treatthe condition.
 11. The system of claim 10 which comprises threeelectrode shafts, each electrode shaft having two or more platinum bandsor contact points and each electrode has a thermal sensor.
 12. Thesystem of claim 10, wherein each electrode shaft has one or moreinflatable components that can be inflated to provide for mechanicalstability while surrounding a defined area.
 13. The system of claim 10which is suitable for treating a medical condition which occurs in theprostate, breast, liver, lungs, brain, pancreas, kidneys, uterus, skin,or ovaries.
 14. The system of claim 10, wherein voltage amplitude andpulse-widths between electrodes can be proportionately varied todynamically shift or steer current vectors anywhere in the defined areain three dimensions, without moving the amplifier electrodes, to ensureproper resistive heating.
 15. A system for treating a condition within apatient's body, which comprises: three or more electrode shafts thatdefine an area, each shaft having at least two electrode bandspositioned along the shaft; a processor configured to generateinstructive signals that are DC arbitrary waveforms or AC arbitrarywaveforms of a frequency of up to about 1 KHz; and an amplifier arrayconfigured to receive instructive signals from the processor and todeliver signals to the electrode bands, wherein the processor isconfigured to control the amplifier array to proportionately vary thevoltage amplitude of signals to the electrode bands to dynamically steerand focus ionic current vectors to create and steer a hot zone anywherein three dimensions within the defined area between the electrode shaftsto resistively heat the defined area to alleviate the condition.
 16. Thesystem of claim 15, wherein each electrode shaft has two or moreplatinum bands or contact points as electrode bands and each electrodeshaft has at least one thermal sensor to provide feedback to theprocessor.
 17. The system of claim 16, wherein the temperatures of thethermal sensors are monitored and the current delivered to eachelectrode band is monitored.
 18. The system of claim 17, wherein thecombination of thermal and current measurements is fed into an algorithmthe processor uses to vary the voltage amplitude.
 19. The system ofclaim 15 which is suitable for treating a condition which occurs in abreast, liver, lungs, brain, pancreas, uterus, prostate, skin, or ovaryor elsewhere within or external to or transcutaneous on a patient'sbody.
 20. The system of claim 15, wherein all the ionic current vectorscombine to generate controlled and focused hyperthermia.
 21. The systemof claim 15 which is configured to electronically steer the ioniccurrent vectors to uniformly elevate areas of the mass to a temperatureof from about 48° C. to about 50° C.
 22. The system of claim 15, whichfurther comprises a grid block, wherein three or more electrode shaftswith electrode bands will be capable of being inserted into holes withinthe grid block while an ultrasound video is used simultaneously as amechanical guide to surround the malignant or benign mass.
 23. A systemfor treating a mass or medical condition within a patient's body whichcomprises: three or more electrode shafts that define an area, eachshaft having at least two electrode bands positioned along the shaft,and a computer processor-controlled electronic amplifier array which isconfigured to deliver signals that are DC arbitrary waveforms or ACarbitrary waveforms of a frequency of up to about 1 KHz to the electrodebands, wherein the computer-controlled processor is configured tocontrol the amplifier array in such a way as to proportionately vary thevoltage amplitude of signals to the electrode bands to dynamically steerand focus ionic current vectors to create and steer a hot zone anywherein three dimensions within the area between the three or more electrodeshafts, and wherein the defined area is resistively heated sufficientlyto treat the condition while minimizing damage to surrounding healthytissue.
 24. A method for treating a mass or medical condition within apatient's body, which comprises: positioning three or more electrodeshafts that define an area, each shalt having at least two electrodebands positioned along the shaft; generating instructive signals from aprocessor that are DC arbitrary waveforms or AC arbitrary waveforms of afrequency of up to about 1 KHz; and receiving the instructive signalsfrom the processor in an amplifier array configured to receive suchsignals and to deliver signals to the electrode bands, wherein theprocessor is configured to control the amplifier array toproportionately vary the voltage amplitude of signals to the electrodebands to dynamically steer and focus ionic current vectors to create andsteer a hot zone anywhere in three dimensions within the defined betweenthe electrode shafts to resistively heat the defined area to treat thecondition.
 25. The method of claim 24, wherein each electrode shaft hasthree electrode bands.
 26. The method of claim 24, wherein theprocessor-controlled electronic amplifier array generates signals todynamically and proportionally steer current vectors under softwarecontrol using a computer.
 27. The method of claim 24 comprising theadditional step of: inserting two or more biopsy probes or needles intoa patient's organ to determine the extent of a defined area.
 28. Themethod of claim 27, wherein the biopsy probes or needles are removedbefore electrode shafts are inserted into the patient.
 29. The method ofclaim 27, wherein biopsy probes or needles are capable of functioning aselectrode shafts having two or more electrode bands.
 30. The method ofclaim 24 for treating a condition which occurs in a breast, liver,lungs, brain, pancreas, uterus, prostate, skin, or ovary or elsewherewithin or external to a patient's body.
 31. The method of claim 24,wherein each electrode shaft has at least one thermal sensor to providefeedback to the processor.
 32. The method of claim 31, wherein theprocessor samples and analyzes thermal data from the thermal sensors andmanages the amplifier-delivered energy by adjusting voltage amplitudesand pulse-widths of waveforms delivered to the electrode bands.
 33. Themethod of claim 24, wherein the ionic current vectors are steered tosubstantially uniformly elevate areas of the mass to a temperature offrom about 48° C. to about 50° C.
 34. The method of claim 24, whereinthree or more electrode shafts with electrode bands will be capable ofbeing inserted into holes within a grid block while an ultrasound videois used simultaneously as a mechanical guide to surround the definedarea.
 35. A system for treating a mass or medical condition external ortranscutaneous on a patient's body, which comprises: three or moreelectrode transcutaneous patches that define an area, each patch havinga geometry that is consistent with the area of skin and a depth oftissue or mass that is to be treated a processor configured to generateinstructive signals that are DC arbitrary waveforms or AC arbitrarywaveforms of a frequency of up to about 1 KHz; and an amplifier arrayconfigured to receive instructive signals from the processor and todeliver signals to the electrode bands, wherein the processor isconfigured to control the amplifier array to proportionately vary thevoltage amplitude of signals to the electrode bands to dynamically steerand focus ionic current vectors to create and steer a hot zone anywherein three dimensions within the defined area between the electrodepatches in concert with one or more subcutaneous electrodes toresistively heat the defined area to alleviate the condition.
 36. Amethod of treating a volume of skin such as a melanoma by treating theskin and/or mass in three dimensions with a system of claim 35 to inducehyperthermia.